Sleep Complete Program Launched

Henry Schein Inc., the largest provider of health care products and services to office-based practitioners, today announced the launch of its Sleep Complete™ program, a new integrated comprehensive solution that provides all of the information and products necessary for the successful implementation of dental sleep medicine into the dental practice. A key component of this package will be Itamar-Medical’s WatchPAT home test device for the diagnosis of obstructive sleep apnea.The Sleep Complete package will be offered to dentists through a bundled financing package which should significantly lower the financial barrier to entry that often faces dentists interested in incorporating sleep medicine into their practice. Read the rest of this entry

Balm Lab Device Diagnose Sleep Apnea From Mattress

Bam Labs aims to make health monitoring easier for people while they sleep. Notably, the company’s sensor is not wearable, but it tracks heart rate, breathing, and movement during sleep, and the company says it can even diagnose sleep apnea — all from a mattress pad located beneath the user.

The Bam Labs device was designed by former Apple employees. It is intended for use both in clinical settings and for home health.

The device functions through a sensor “at one corner of the pad. Air-pressure fluctuations caused by the tiny tremors caused by heartbeats or the more sizable shaking that occurs when someone turns over or gets out of bed are measured and controlled. Read the rest of this entry

ResMed S9:A Great Design in Medical Devices

The ResMed S9 is a uniquly designed sleep apnea device and only because of this the device ResMed S9 won a Red Dot design award last year.

Michael Farrell, senior vice president at ResMed’s global sleep strategic business unit, said: “Great design in medical devices should combine good looks, innovation and user-friendliness, as well as address an unmet medical need.”

The device uses special quality plastics in its manufacturing. This is called the “ Cycoloy polycarbonate/acrylonitrile-butadiene-styrene (PC/ABS) resin”.Sabic Innovative Plastics is the company that manufactures the ”Lexan and Cycoloy materials” that have been used in the making of the award-winning ResMed S9 series of sleep apnea devices.

Sabic’s Cycoloy polycarbonate/acrylonitrile-butadiene-styrene (PC/ABS) resin is used to mould the complex, thin-wall S9 chassis. The high-flow material uses a non-halogenated flame retardant.

The tough Sabic Lexan polycarbonate is biocompatible and has a high-quality surface finish. It is used for the S9 top case and also in ResMed’s H5i humidifier flip lid.

The company says: “These new devices are designed with the SABIC Lexan and Cycoloy resin materials to be unobtrusive in the home – looking more like a clock radio or stereo than a piece of medical equipment.”

RespireAide Sleep Apnea Device Gets Patent

Harry Cutler, a sleep apnea patient, has been awarded patent protection in the United Kingdom. The patent protects a medical device created initially to treat Mr. Cutler’s own obstructive sleep apnea (OSA) which afflicts from 12% to 25% of the population. The device also reduces or eliminates snoring, one of the primary side effects of OSA. Unlike other oral appliances, it can be used by people with loose teeth, dentures, or no teeth at all, thereby eliminating costly dental preparation. It is being marketed as the “RespireAide Sleep Apnea Solution”.

In this case, necessity was indeed the mother of invention. Underemployed at the time and without insurance, Cutler’s sleep apnea became severe. “I was falling asleep while driving to work, in the middle of the day! I had to do something,” said Cutler.

He researched the condition and began to fashion a solution mostly from items found around the house or purchased from the local hardware and sporting goods stores. “The initial device was somewhat crude, but it did help. Over the following six years, using myself as a test subject, I refined and improved the device with the goal of creating an acceptable combination of comfort and effectiveness. The resultant device bears little resemblance to the original,” he added. Read the rest of this entry

SleepApneaDisorder/[ Press Release ]/HOUSTON/Cyberonics, Inc.  a global leader in medical devices for the treatment and management of epilepsy, today announced an initial investment of $4 million in ImThera Medical, Inc. (“ImThera“). Based in San Diego, California, ImThera is an early-stage company developing a novel, implantable neurostimulation device for the treatment of obstructive sleep apnea (“OSA”).

The investment in ImThera can total $12 million subject to the achievement of certain regulatory and clinical milestones. Cyberonics is a minority shareholder with certain rights, including representation on ImThera’s board of directors. In addition, ImThera will raise up to $4 million from its private investors, for a total Series C placement of up to $16 million.

OSA is a serious, potentially life-threatening condition associated with significant long-term health problems and accompanying costs. ImThera’s Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy combines a multi-contact electrode specifically designed to control certain muscles of the tongue with an implantable pulse generator and an external programmer. The company is currently pursuing CE Mark regulatory approval in the European Union and expects to initiate a pivotal clinical trial in the U.S. in the near future. Read the rest of this entry

Provent Sleep Apnea Therapy Launched in India

SleepApneaDisorder/[ Press Release ]/ BELMONT, Calif. and HYDERABAD, India, July 20, 2011 /- Ventus Medical is pleased to announce the Indian launch of its proprietary Provent® Sleep Apnea Therapy, an innovative, non-invasive treatment for obstructive sleep apnea (OSA). Orbees Business Solutions Pvt. Ltd. will be the strategic market developer of Provent Therapy in India.

India has a very high prevalence of obstructive sleep apnea. Roughly 20% of urban Indian males suffer from OSA,” said Rajiv Doshi, M.D., Chief Scientific Officer of Ventus Medical and inventor of the Provent technology. Dr. Doshi is faculty at Stanford University and serves as Executive Director (US) of the Stanford India Biodesign program, a Government of India funded collaboration between Stanford University and the All India Institute of Medical Sciences (AIIMS) and the Indian Institute of Technology Delhi. “With a very large patient need, we believe that Provent Therapy provides a reliable and clinically-proven solution to treat the millions of people in India with OSA.” Read the rest of this entry

SomnoMed At SLEEP 2011 in Minneapolis

The annual conference SLEEP 2011 was held this year in Minneapolis, Minnesota. Every year it is the world’s most important SLEEP Dental and SLEEP Medical event. This year over 800 delegates attended the dental sleep conference of the AADSM (American Association of Dental Sleep Medicine) and more than 5,000 delegates joined the medical sleep conference of the APSS (Associated Professional Sleep Societies).

SomnoMed had a strong presence in both events and reported the highest number of leads and  professional contacts on record. It was a very successful event and again underlined the increasing recognition of SomnoMed as the world’s leading company in the Dental Sleep Medical field. Read the rest of this entry

SleepApneaDisorder/[Press Release ]/Minneapolis, MN/June 29, 2011/-Somnetics, International Inc., the maker of the Transcend travel CPAP, is pleased to announce the addition of four new dealers to its list of dealers selling Transcend. They include:

A.W.C.S. Medical
1392 Oliver, Ste D
Porterville, California 93257
559-784-3333

AV Respiratory Services
1601 W Ave J, Ste 201
Lancaster, California 93534

Perry Home Medical Supply
530 Park Ave East
Princeton, Illinois 61356
815-876-3068

Northshore Sleep Medicine
3451 Church Street
Evenson, Illinois 60203
847-674-3600 Read the rest of this entry

Battery packs are now available for Transcendthe new wearable sleep apnea therapy device designed to be the ultimate travel  CPAP. A convenient optional power source, these Lithium Ion packs are available  in 4-cell and 8-cell sizes.

Battery life for the packs will depend on the pressure setting and breathing  patterns of each individual user. The 4-cell battery pack will power Transcend for approximately 7 to 9 hours and the 8-cell battery pack will power Transcend for approximately 14 to 16 hours. The battery packs may be charged with AC line  power or with a mobile power adapter and must be fully charged before the first  use. Charge time for the 4-cell may take five hours; the 8-cell may take as much  as eight hours.

In addition to being used as a power source, the battery packs serve as a  power source backup when used with AC line power. Should the power go out,  Transcend will continue to provide patients with therapy.

Transcend battery packs come with adjustable chest and arm straps. Patients  may choose to strap the battery pack to their chest or arm, or simply put it  under their pillow. Read the rest of this entry

Sleep apnea testing generally requires an overnight stay in a sleep clinic, tens of wires attached to your head and body (glued), and tubes inserted into your nose and in front of your mouth. This setup makes for a difficult sleep on top of existing abnormalities, and, because the clinics need to be staffed all night, is relatively expensive.

Watermark Medical, out of Boca Raton, Florida, provides at home diagnostic solutions for sleep disorders such as sleep apnea by giving patients a headset, of sorts, to wear at home during sleep. Their device, the ARES Unicoder, collects O2 saturation, nasal airflow, pulse rate, snoring, head movement, and REM/NREM via an EEG. This data is combined with clinical indicators to provide an apnea index and respiratory disturbance index that allows physicians to diagnose sleep apnea.

The product, named by the Cleveland Clinic as a top 10 medical innovation of 2010, is being marketed as a reimbursable, less expensive alternative to in-lab sleep apnea testing.

SeptRx,an emerging medical device company that is developing the SeptRx® Intrapocket PFO Occluder (IPO)—a platform for the percutaneous transcatheter closure of a heart defect known as patent foramen ovale (PFO)—announced today that the company has received $2.7 million in a ‘Series A’ financing led by NDC (Nitinol Devices & Components) Inc. The cash infusion is intended to “carry us through CE mark registration,” said Scott Russell, President and CEO of SeptRx.

The SeptRx® Intrapocket PFO Occluder has already completed a successful 11-patient first-in-human (FIH) clinical trial. SeptRx’s FIH trial was the first and only PFO device trial to demonstrate 100% closure and 100% safety (out to 3 years). A larger European clinical trial is nearly underway: InterSEPT (In-tunnel SeptRx European PFO Trial), from which data will be used to apply for CE marking. The trial will be conducted at two investigation sites: Frankfurt, Germany, and Massy,France. Read the rest of this entry

A North Bay startup that’s developing diagnostic equipment for sleep apnea plans to move to Sonoma County after winning a competition giving it free office space and professional support for a year.

The contest was organized by North Bay iHub, an economic development group connected with the Sonoma Mountain Business Cluster, which is providing the office space. A pool of 36 contestants competed for a prize package worth $40,000 which also included cash and legal, marketing and accounting services.

K-diagnostics, based partly in San Rafael, is developing touchless technology to diagnose and monitor sleep apnea. The technology, called “Sleep ID,” can be used in a home or a medical setting and uses low-power radar to measure respiratory and heart rates.

The prevalence of sleep apnea is actually quite strong now. There are more than 40 million Americans affected.The company is planning to move into the Rohnert Park business cluster and employ a staff of 30 by the end of 2012.

Based on its recent analysis of the neurostimulation for sleep apnea market, Frost & Sullivan recognizes ImThera Medical, Inc. with the 2011 North American Frost & Sullivan Award for Technology Innovation for its pioneering sleep apnea device, the aura6000™.

Continuous positive airway pressure (CPAP) treatment, the gold standard for treating obstructive sleep apnea (OSA), has poor patient compliance due to the inconvenience involved. ImThera is one of the few companies to have devised a neurostimulation device for treating OSA that targets CPAP non-compliant patients worldwide (at least 46 percent of patients according to market data) and can also be used for others as a second line of therapy for OSA. Read the rest of this entry

SleepApneaDisorder/ [ Press Release ]/ Minneapolis, MN/ April 04, 2011/- Through April 30, 2011, Somnetics, LLC is partnering with participating  medical equipment dealers to offer sleep apnea  patients a chance to try the Transcend Sleep Apnea Therapy System through a 30-day money-back guarantee.

Virtually unheard of in the CPAP industry, sleep apnea patients will be able  to test-drive Transcend for 30 days before committing to the purchase of the  CPAP.  If customers are unsatisfied with Transcend for any reason, they may  return Transcend to the dealer from which they purchased it within 30 days of  the original purchase date for a full refund. Read the rest of this entry

SleepApneaDisorder/ [ Press Release ]/ BELMONT, Calif., April 4, 2011 / — Ventus Medical, Inc. today reported positive results from a 19 center clinical trial using its FDA-cleared Provent® Sleep Apnea Therapy device to treat obstructive sleep apnea. Provent Therapy uses the patient’s own breathing to create expiratory positive airway pressure (EPAP) to keep the airway open during sleep. The full results of this three month study were published in the April 2011 issue of the peer-reviewed medical journal SLEEP, an official publication of the American Academy of Sleep Medicine.

“This randomized, sham-controlled study demonstrates that Provent Therapy significantly improves the apnea hypopnea index (AHI), a scale to measure the number of breathing interruptions or stoppages per hour of sleep, as well as subjective sleepiness, as measured by the Epworth Sleepiness Scale (ESS) in patients with obstructive sleep apnea,” said study author Richard B. Berry, M.D., professor of medicine at the University of Florida College of Medicine, medical director of the University of Florida and Shands Sleep Disorders Center, and former president of the American Sleep Medicine Foundation. “Importantly, self-reported patient adherence on Provent Therapy was almost 90 percent.” Read the rest of this entry

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